Early sustained unresponsiveness after short-course egg oral immunotherapy: A randomized controlled study in egg-allergic children

Abstract

Background: No studies have evaluated the potential of egg oral immunotherapy (egg-OIT) to induce sustained unresponsiveness after discontinuing therapy following short-term treatments. Objective: We assessed the efficacy of short-course egg-OIT to induce sustained unresponsiveness. Methods: Sixty-one egg-allergic children, 5 to 17 years old, with positive double-blind placebo-controlled food challenge (DBPCFC) to dehydrated egg white (EW) were randomized to receive egg-OIT (OITG) for 3 months (maintenance dose one undercooked egg every 48 hours) or to continue egg avoidance diet (control group, CG) for 4 months. Children who completed egg-OIT avoided egg for 1 month. At 4 months, both groups underwent a DBPCFC. OITG participants who passed this challenge were instructed to add egg to their diet ad libitum. Immune markers were studied at different time points. Results: Ninety-three percent (28/30) of OITG children were desensitized in a median of 32.5 days (IQR, 14 days). At 4 months, 1/31 (3%) in CG passed DBPCFC and 11/30(37%) of OITG (95% CI, 14 to 51%; P = 0.003), all of them were consuming egg at 36 months. A decrease in EW, OVA and OVM skin test results and OVA-specific IgE (sIgE) levels was observed on OITG at 4 months (P = 0.001). EW-, OVA- and OVM-sIgE levels prior to the start of egg avoidance diet were lower in OITG children who passed DBPCFC at 4 months than in those who did not pass it. EW- and OVM-sIgE showed the best diagnostic performance in predicting DBPCFC result at 4 months. Levels above optimal EW-sIgE cut-off of 7.1 kU/L indicated 90% probability of failing DBPCFC. Conclusion: This is the first demonstration of sustained unresponsiveness with a three-month egg-OIT protocol. Almost all treated subjects were desensitized and 37% achieved sustained unresponsiveness. EW-sIgE levels at the end of treatment predicted sustained unresponsiveness. This protocol shows a new approach to OIT for egg-allergic children.